s. 2032...3 †s 2032 es 1 trolled substance on the schedule that is applicable 2 to cannabidiol or...

26
116TH CONGRESS 2D SESSION S. 2032 AN ACT To expand research on the cannabidiol and marihuana. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2

Upload: others

Post on 21-Feb-2021

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

116TH CONGRESS 2D SESSION S. 2032

AN ACT To expand research on the cannabidiol and marihuana.

Be it enacted by the Senate and House of Representa-1

tives of the United States of America in Congress assembled, 2

Page 2: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

2

† S 2032 ES

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 1

(a) SHORT TITLE.—This Act may be cited as the 2

‘‘Cannabidiol and Marihuana Research Expansion Act’’. 3

(b) TABLE OF CONTENTS.—The table of contents for 4

this Act is as follows: 5

Sec. 1. Short title; table of contents.

Sec. 2. Definitions.

TITLE I—REGISTRATIONS FOR MARIHUANA RESEARCH

Sec. 101. Marihuana research applications.

Sec. 102. Research protocols.

Sec. 103. Applications to manufacture marihuana for research.

Sec. 104. Adequate and uninterrupted supply.

Sec. 105. Security requirements.

Sec. 106. Prohibition against reinstating interdisciplinary review process for

non-NIH funded researchers.

TITLE II—DEVELOPMENT OF FDA-APPROVED DRUGS USING

CANNABIDIOL AND MARIHUANA

Sec. 201. Medical research on cannabidiol.

Sec. 202. Registration for the commercial production and distribution of Food

and Drug Administration approved drugs.

Sec. 203. Importation of cannabidiol for research purposes.

TITLE III—DOCTOR-PATIENT RELATIONSHIP

Sec. 301. Doctor-patient relationship.

TITLE IV—FEDERAL RESEARCH

Sec. 401. Federal research.

SEC. 2. DEFINITIONS. 6

In this Act— 7

(1) the term ‘‘appropriately registered’’ means 8

that an individual or entity is registered under the 9

Controlled Substances Act (21 U.S.C. 801 et seq.) 10

to engage in the type of activity that is carried out 11

by the individual or entity with respect to a con-12

Page 3: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

3

† S 2032 ES

trolled substance on the schedule that is applicable 1

to cannabidiol or marihuana, as applicable; 2

(2) the term ‘‘cannabidiol’’ means— 3

(A) the substance, cannabidiol, as derived 4

from marihuana that has a delta–9 5

tetrahydrocannabinol level that is greater than 6

0.3 percent; and 7

(B) the synthetic equivalent of the sub-8

stance described in subparagraph (A); 9

(3) the terms ‘‘controlled substance’’, ‘‘dis-10

pense’’, ‘‘distribute’’, ‘‘manufacture’’, ‘‘marihuana’’, 11

and ‘‘practitioner’’ have the meanings given such 12

terms in section 102 of the Controlled Substances 13

Act (21 U.S.C. 802), as amended by this Act; 14

(4) the term ‘‘covered institution of higher edu-15

cation’’ means an institution of higher education (as 16

defined in section 101 of the Higher Education Act 17

of 1965 (20 U.S.C. 1001)) that— 18

(A)(i) has highest or higher research activ-19

ity, as defined by the Carnegie Classification of 20

Institutions of Higher Education; or 21

(ii) is an accredited medical school or an 22

accredited school of osteopathic medicine; and 23

Page 4: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

4

† S 2032 ES

(B) is appropriately registered under the 1

Controlled Substances Act (21 U.S.C. 801 et 2

seq.); 3

(5) the term ‘‘drug’’ has the meaning given the 4

term in section 201(g)(1) of the Federal Food, 5

Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)); 6

(6) the term ‘‘medical research for drug devel-7

opment’’ means medical research that is— 8

(A) a preclinical study or clinical investiga-9

tion conducted in accordance with section 10

505(i) of the Federal Food, Drug, and Cos-11

metic Act (21 U.S.C. 355(i)) or otherwise per-12

mitted by the Department of Health and 13

Human Services to determine the potential 14

medical benefits of marihuana or cannabidiol as 15

a drug; and 16

(B) conducted by a covered institution of 17

higher education, practitioner, or manufacturer 18

that is appropriately registered under the Con-19

trolled Substances Act (21 U.S.C. 801 et seq.); 20

and 21

(7) the term ‘‘State’’ means any State of the 22

United States, the District of Columbia, and any 23

territory of the United States. 24

Page 5: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

5

† S 2032 ES

TITLE I—REGISTRATIONS FOR 1

MARIHUANA RESEARCH 2

SEC. 101. MARIHUANA RESEARCH APPLICATIONS. 3

Section 303(f) of the Controlled Substances Act (21 4

U.S.C. 823(f)) is amended— 5

(1) by redesignating paragraphs (1) through 6

(5) as subparagraphs (A) through (E), respectively; 7

(2) by striking ‘‘(f) The Attorney General’’ and 8

inserting ‘‘(f)(1) The Attorney General’’; 9

(3) by striking ‘‘Registration applications’’ and 10

inserting the following: 11

‘‘(2)(A) Registration applications’’; 12

(4) by striking ‘‘Article 7’’ and inserting the 13

following: 14

‘‘(3) Article 7’’; and 15

(5) by inserting after paragraph (2)(A), as so 16

designated, the following: 17

‘‘(B)(i) The Attorney General shall register a practi-18

tioner to conduct research with marihuana if— 19

‘‘(I) the applicant’s research protocol— 20

‘‘(aa) has been reviewed and allowed— 21

‘‘(AA) by the Secretary of Health and 22

Human Services under section 505(i) of 23

the Federal Food, Drug, and Cosmetic Act 24

(21 U.S.C. 355(i)); 25

Page 6: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

6

† S 2032 ES

‘‘(BB) by the National Institutes of 1

Health or another Federal agency that 2

funds scientific research; or 3

‘‘(CC) pursuant to sections 1301.18 4

and 1301.32 of title 21, Code of Federal 5

Regulations, or any successors thereto; and 6

‘‘(II) the applicant has demonstrated to the At-7

torney General that there are effective procedures in 8

place to adequately safeguard against diversion of 9

the controlled substance for legitimate medical or 10

scientific use pursuant to section 105 of the 11

Cannabidiol and Marihuana Research Expansion 12

Act, including demonstrating that the security meas-13

ures are adequate for storing the quantity of mari-14

huana the applicant would be authorized to possess. 15

‘‘(ii) The Attorney General may deny an application 16

for registration under this subparagraph only if the Attor-17

ney General determines that the issuance of the registra-18

tion would be inconsistent with the public interest. In de-19

termining the public interest, the Attorney General shall 20

consider the factors listed in— 21

‘‘(I) subparagraphs (B) through (E) of para-22

graph (1); and 23

‘‘(II) subparagraph (A) of paragraph (1), if the 24

applicable State requires practitioners conducting re-25

Page 7: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

7

† S 2032 ES

search to register with a board or authority de-1

scribed in such subparagraph (A). 2

‘‘(iii)(I) Not later than 60 days after the date on 3

which the Attorney General receives a complete applica-4

tion for registration under this subparagraph, the Attor-5

ney General shall— 6

‘‘(aa) approve the application; or 7

‘‘(bb) request supplemental information. 8

‘‘(II) For purposes of subclause (I), an application 9

shall be deemed complete when the applicant has sub-10

mitted documentation showing that the requirements 11

under clause (i) are satisfied. 12

‘‘(iv) Not later than 30 days after the date on which 13

the Attorney General receives supplemental information as 14

described in clause (iii)(I)(bb) in connection with an appli-15

cation described in this subparagraph, the Attorney Gen-16

eral shall approve or deny the application. 17

‘‘(v) If an application described in this subparagraph 18

is denied, the Attorney General shall provide a written ex-19

planation of the basis of denial to the applicant.’’. 20

SEC. 102. RESEARCH PROTOCOLS. 21

(a) IN GENERAL.—Paragraph (2)(B) of section 22

303(f) of the Controlled Substances Act (21 U.S.C. 23

823(f)), as amended by section 101 of this Act, is further 24

amended by adding at the end the following: 25

Page 8: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

8

† S 2032 ES

‘‘(vi)(I) If the Attorney General grants an application 1

for registration under clause (i), the registrant may amend 2

or supplement the research protocol without reapplying if 3

the registrant does not change— 4

‘‘(aa) the quantity or type of drug; 5

‘‘(bb) the source of the drug; or 6

‘‘(cc) the conditions under which the drug is 7

stored, tracked, or administered. 8

‘‘(II)(aa) If a registrant under clause (i) seeks to 9

change the type of drug, the source of the drug, or condi-10

tions under which the drug is stored, tracked, or adminis-11

tered, the registrant shall notify the Attorney General via 12

registered mail, or an electronic means permitted by the 13

Attorney General, not later than 30 days before imple-14

menting an amended or supplemental research protocol. 15

‘‘(bb) A registrant may proceed with an amended or 16

supplemental research protocol described in item (aa) if 17

the Attorney General does not explicitly object during the 18

30-day period beginning on the date on which the Attorney 19

General receives the notice under item (aa). 20

‘‘(cc) The Attorney General may only object to an 21

amended or supplemental research protocol under this 22

subclause if additional security measures are needed to 23

safeguard against diversion or abuse. 24

Page 9: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

9

† S 2032 ES

‘‘(dd) If a registrant under clause (i) seeks to address 1

additional security measures identified by the Attorney 2

General under item (cc), the registrant shall notify the At-3

torney General via registered mail, or an electronic means 4

permitted by the Attorney General, not later than 30 days 5

before implementing an amended or supplemental research 6

protocol. 7

‘‘(ee) A registrant may proceed with an amended or 8

supplemental research protocol described in item (dd) if 9

the Attorney General does not explicitly object during the 10

30-day period beginning on the date on which the Attorney 11

General receives the notice under item (dd). 12

‘‘(III)(aa) If a registrant under clause (i) seeks to 13

change the quantity of marihuana needed for research and 14

the change in quantity does not impact the factors de-15

scribed in item (bb) or (cc) of subclause (I) of this clause, 16

the registrant shall notify the Attorney General via reg-17

istered mail or using an electronic means permitted by the 18

Attorney General. 19

‘‘(bb) A notification under item (aa) shall include— 20

‘‘(AA) the Drug Enforcement Administration 21

registration number of the registrant; 22

‘‘(BB) the quantity of marihuana already ob-23

tained; 24

Page 10: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

10

† S 2032 ES

‘‘(CC) the quantity of additional marihuana 1

needed to complete the research; and 2

‘‘(DD) an attestation that the change in quan-3

tity does not impact the source of the drug or the 4

conditions under which the drug is stored, tracked, 5

or administered. 6

‘‘(cc) The Attorney General shall ensure that— 7

‘‘(AA) any registered mail return receipt 8

with respect to a notification under item (aa) is 9

submitted for delivery to the registrant pro-10

viding the notification not later than 3 days 11

after receipt of the notification by the Attorney 12

General; and 13

‘‘(BB) notice of receipt of a notification 14

using an electronic means permitted under item 15

(aa) is provided to the registrant providing the 16

notification not later than 3 days after receipt 17

of the notification by the Attorney General. 18

‘‘(dd)(AA) On and after the date described in 19

subitem (BB), a registrant that submits a notifica-20

tion in accordance with item (aa) may proceed with 21

the research as if the change in quantity has been 22

approved on such date, unless the Attorney General 23

notifies the registrant of an objection described in 24

item (ee). 25

Page 11: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

11

† S 2032 ES

‘‘(BB) The date described in this subitem is the 1

date on which a registrant submitting a notification 2

under item (aa) receives the registered mail return 3

receipt with respect to the notification or the date on 4

which the registrant receives notice that the notifica-5

tion using an electronic means permitted under item 6

(aa) was received by the Attorney General, as the 7

case may be. 8

‘‘(ee) A notification submitted under item (aa) 9

shall be deemed to be approved unless the Attorney 10

General, not later than 10 days after receiving the 11

notification, explicitly objects based on a finding that 12

the change in quantity— 13

‘‘(AA) does impact the source of the drug 14

or the conditions under which the drug is 15

stored, tracked, or administered; or 16

‘‘(BB) necessitates that the registrant im-17

plement additional security measures to safe-18

guard against diversion or abuse. 19

‘‘(IV) Nothing in this clause shall limit the authority 20

of the Secretary of Health and Human Services over re-21

quirements related to research protocols, including 22

changes in— 23

‘‘(aa) the method of administration of mari-24

huana; 25

Page 12: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

12

† S 2032 ES

‘‘(bb) the dosing of marihuana; and 1

‘‘(cc) the number of individuals or patients in-2

volved in research.’’. 3

(b) REGULATIONS.—Not later than 1 year after the 4

date of enactment of this Act, the Attorney General shall 5

promulgate regulations to carry out the amendment made 6

by this section. 7

SEC. 103. APPLICATIONS TO MANUFACTURE MARIHUANA 8

FOR RESEARCH. 9

(a) IN GENERAL.—Section 303 of the Controlled 10

Substances Act (21 U.S.C. 823) is amended— 11

(1) by redesignating subsections (c) through (k) 12

as subsections (d) through (l), respectively; 13

(2) by inserting after subsection (b) the fol-14

lowing: 15

‘‘(c)(1)(A) As it relates to applications to manufac-16

ture marihuana for research purposes, if the Attorney 17

General places a notice in the Federal Register to increase 18

the number of entities registered under this Act to manu-19

facture marihuana to supply appropriately registered re-20

searchers in the United States, the Attorney General shall, 21

not later than 60 days after the date on which the Attor-22

ney General receives a completed application— 23

‘‘(i) approve the application; or 24

‘‘(ii) request supplemental information. 25

Page 13: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

13

† S 2032 ES

‘‘(B) For purposes of subparagraph (A), an applica-1

tion shall be deemed complete when the applicant has sub-2

mitted documentation showing each of the following: 3

‘‘(i) The requirements designated in the notice 4

in the Federal Register are satisfied. 5

‘‘(ii) The requirements under this Act are satis-6

fied. 7

‘‘(iii) The applicant will limit the transfer and 8

sale of any marihuana manufactured under this sub-9

section— 10

‘‘(I) to researchers who are registered 11

under this Act to conduct research with con-12

trolled substances in schedule I; and 13

‘‘(II) for purposes of use in preclinical re-14

search or in a clinical investigation pursuant to 15

an investigational new drug exemption under 16

505(i) of the Federal Food, Drug, and Cos-17

metic Act (21 U.S.C. 355(i)). 18

‘‘(iv) The applicant will transfer or sell any 19

marihuana manufactured under this subsection only 20

with prior, written consent for the transfer or sale 21

by the Attorney General. 22

‘‘(v) The applicant has completed the applica-23

tion and review process under subsection (a) for the 24

Page 14: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

14

† S 2032 ES

bulk manufacture of controlled substances in sched-1

ule I. 2

‘‘(vi) The applicant has established and begun 3

operation of a process for storage and handling of 4

controlled substances in schedule I, including for in-5

ventory control and monitoring security in accord-6

ance with section 105 of the Cannabidiol and Mari-7

huana Research Expansion Act. 8

‘‘(vii) The applicant is licensed by each State in 9

which the applicant will conduct operations under 10

this subsection, to manufacture marihuana, if that 11

State requires such a license. 12

‘‘(C) Not later than 30 days after the date on which 13

the Attorney General receives supplemental information 14

requested under subparagraph (A)(ii) with respect to an 15

application, the Attorney General shall approve or deny 16

the application. 17

‘‘(2) If an application described in this subsection is 18

denied, the Attorney General shall provide a written expla-19

nation of the basis of denial to the applicant.’’; 20

(3) in subsection (h)(2), as so redesignated, by 21

striking ‘‘subsection (f)’’ each place it appears and 22

inserting ‘‘subsection (g)’’; 23

Page 15: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

15

† S 2032 ES

(4) in subsection (j)(1), as so redesignated, by 1

striking ‘‘subsection (d)’’ and inserting ‘‘subsection 2

(e)’’; and 3

(5) in subsection (k), as so redesignated, by 4

striking ‘‘subsection (f)’’ each place it appears and 5

inserting ‘‘subsection (g)’’. 6

(b) TECHNICAL AND CONFORMING AMENDMENTS.— 7

(1) The Controlled Substances Act (21 U.S.C. 8

801 et seq.) is amended— 9

(A) in section 102 (21 U.S.C. 802)— 10

(i) in paragraph (16)(B)— 11

(I) in clause (i), by striking ‘‘or’’ 12

at the end; 13

(II) by redesignating clause (ii) 14

as (iii); and 15

(III) by inserting after clause (i) 16

the following: 17

‘‘(ii) the synthetic equivalent of hemp-de-18

rived cannabidiol that contains less than 0.3 19

percent tetrahydrocannabinol; or’’; 20

(ii) in paragraph (52)(B)— 21

(I) by striking ‘‘303(f)’’ each 22

place it appears and inserting 23

‘‘303(g)’’; and 24

Page 16: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

16

† S 2032 ES

(II) in clause (i), by striking 1

‘‘(d), or (e)’’ and inserting ‘‘(e), or 2

(f)’’; and 3

(iii) in paragraph (54), by striking 4

‘‘303(f)’’ each place it appears and insert-5

ing ‘‘303(g)’’; 6

(B) in section 302(g)(5)(A)(iii)(I)(bb) (21 7

U.S.C. 822(g)(5)(A)(iii)(I)(bb)), by striking 8

‘‘303(f)’’ and inserting ‘‘303(g)’’; 9

(C) in section 304 (21 U.S.C. 824), by 10

striking ‘‘303(g)(1)’’ each place it appears and 11

inserting ‘‘303(h)(1)’’; 12

(D) in section 307(d)(2) (21 U.S.C. 13

827(d)(2)), by striking ‘‘303(f)’’ and inserting 14

‘‘303(g)’’; 15

(E) in section 309A(a)(2) (21 U.S.C. 16

829a(a)(2)), in the matter preceding subpara-17

graph (A), by striking ‘‘303(g)(2)’’ and insert-18

ing ‘‘303(h)(2)’’; 19

(F) in section 311(h) (21 U.S.C. 831(h)), 20

by striking ‘‘303(f)’’ each place it appears and 21

inserting ‘‘303(g)’’; 22

(G) in section 401(h)(2) (21 U.S.C. 23

841(h)(2)), by striking ‘‘303(f)’’ each place it 24

appears and inserting ‘‘303(g)’’; 25

Page 17: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

17

† S 2032 ES

(H) in section 403(c)(2)(B) (21 U.S.C. 1

843(c)(2)(B)), by striking ‘‘303(f)’’ and insert-2

ing ‘‘303(g)’’; and 3

(I) in section 512(c)(1) (21 U.S.C. 4

882(c)(1)) by striking ‘‘303(f)’’ and inserting 5

‘‘303(g)’’. 6

(2) Section 1008(c) of the Controlled Sub-7

stances Import and Export Act (21 U.S.C. 958(c)) 8

is amended— 9

(A) in paragraph (1), by striking ‘‘303(d)’’ 10

and inserting ‘‘303(e)’’; and 11

(B) in paragraph (2)(B), by striking 12

‘‘303(h)’’ and inserting ‘‘303(i)’’. 13

(3) Title V of the Public Health Service Act (42 14

U.S.C. 290aa et seq.) is amended— 15

(A) in section 520E–4(c) (42 U.S.C. 16

290bb–36d(c)), by striking ‘‘303(g)(2)(B)’’ and 17

inserting ‘‘303(h)(2)(B)’’; and 18

(B) in section 544(a)(3) (42 U.S.C. 19

290dd–3(a)(3)), by striking ‘‘303(g)’’ and in-20

serting ‘‘303(h)’’. 21

(4) Title XVIII of the Social Security Act (42 22

U.S.C. 1395 et seq.) is amended— 23

Page 18: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

18

† S 2032 ES

(A) in section 1833(bb)(3)(B) (42 U.S.C. 1

1395l(bb)(3)(B)), by striking ‘‘303(g)’’ and in-2

serting ‘‘303(h)’’; 3

(B) in section 1834(o)(3)(C)(ii) (42 U.S.C. 4

1395m(o)(3)(C)(ii)), by striking ‘‘303(g)’’ and 5

inserting ‘‘303(h)’’; and 6

(C) in section 1866F(c)(3)(C) (42 U.S.C. 7

1395cc–6(c)(3)(C)), by striking ‘‘303(g)’’ and 8

inserting ‘‘303(h)’’. 9

(5) Section 1903(aa)(2)(C)(ii) of the Social Se-10

curity Act (42 U.S.C. 1396b(aa)(2)(C)(ii)) is 11

amended by striking ‘‘303(g)’’ each place it appears 12

and inserting ‘‘303(h)’’. 13

SEC. 104. ADEQUATE AND UNINTERRUPTED SUPPLY. 14

On an annual basis, the Attorney General shall assess 15

whether there is an adequate and uninterrupted supply of 16

marihuana, including of specific strains, for research pur-17

poses. 18

SEC. 105. SECURITY REQUIREMENTS. 19

(a) IN GENERAL.—An individual or entity engaged 20

in researching marihuana or its components shall store it 21

in a securely locked, substantially constructed cabinet. 22

(b) REQUIREMENTS FOR OTHER MEASURES.—Any 23

other security measures required by the Attorney General 24

to safeguard against diversion shall be consistent with 25

Page 19: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

19

† S 2032 ES

those required for practitioners conducting research on 1

other controlled substances in schedules I and II in section 2

202(c) of the Controlled Substances Act (21 U.S.C. 3

812(c)) that have a similar risk of diversion and abuse. 4

SEC. 106. PROHIBITION AGAINST REINSTATING INTER-5

DISCIPLINARY REVIEW PROCESS FOR NON- 6

NIH FUNDED RESEARCHERS. 7

The Secretary of Health and Human Services may 8

not— 9

(1) reinstate the Public Health Service inter-10

disciplinary review process described in the guidance 11

entitled ‘‘Guidance on Procedures for the Provision 12

of Marijuana for Medical Research’’ (issued on May 13

21, 1999); or 14

(2) require another review of scientific protocols 15

that is applicable only to research on marihuana or 16

its components. 17

TITLE II—DEVELOPMENT OF 18

FDA-APPROVED DRUGS 19

USING CANNABIDIOL AND 20

MARIHUANA 21

SEC. 201. MEDICAL RESEARCH ON CANNABIDIOL. 22

Notwithstanding any provision of the Controlled Sub-23

stances Act (21 U.S.C. 801 et seq.), the Safe and Drug- 24

Free Schools and Communities Act (20 U.S.C. 7101 et 25

Page 20: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

20

† S 2032 ES

seq.), chapter 81 of title 41, United States Code, or any 1

other Federal law, an appropriately registered covered in-2

stitution of higher education, a practitioner, or a manufac-3

turer may manufacture, distribute, dispense, or possess 4

marihuana or cannabidiol if the marihuana or cannabidiol 5

is manufactured, distributed, dispensed, or possessed, re-6

spectively, for purposes of medical research for drug devel-7

opment or subsequent commercial production in accord-8

ance with section 202. 9

SEC. 202. REGISTRATION FOR THE COMMERCIAL PRODUC-10

TION AND DISTRIBUTION OF FOOD AND 11

DRUG ADMINISTRATION APPROVED DRUGS. 12

The Attorney General shall register an applicant to 13

manufacture or distribute cannabidiol or marihuana for 14

the purpose of commercial production of a drug containing 15

or derived from marihuana that is approved by the Sec-16

retary of Health and Human Services under section 505 17

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 18

355), in accordance with the applicable requirements 19

under subsection (a) or (b) of section 303 of the Con-20

trolled Substances Act (21 U.S.C. 823). 21

SEC. 203. IMPORTATION OF CANNABIDIOL FOR RESEARCH 22

PURPOSES. 23

The Controlled Substances Import and Export Act 24

(21 U.S.C. 951 et seq.) is amended— 25

Page 21: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

21

† S 2032 ES

(1) in section 1002(a) (21 U.S.C. 952(a))— 1

(A) in paragraph (1), by striking ‘‘and’’ at 2

the end; 3

(B) in paragraph (2)(C), by inserting 4

‘‘and’’ after ‘‘uses,’’; and 5

(C) inserting before the undesignated mat-6

ter following paragraph (2)(C) the following: 7

‘‘(3) such amounts of marihuana or cannabidiol 8

(as defined in section 2 of the Cannabidiol and Mar-9

ihuana Research Expansion Act) as are— 10

‘‘(A) approved for medical research for 11

drug development (as such terms are defined in 12

section 2 of the Cannabidiol and Marihuana Re-13

search Expansion Act), or 14

‘‘(B) necessary for registered manufactur-15

ers to manufacture drugs containing marihuana 16

or cannabidiol that have been approved for use 17

by the Commissioner of Food and Drugs under 18

the Federal Food, Drug, and Cosmetic Act (21 19

U.S.C. 301 et seq.),’’; and 20

(2) in section 1007 (21 U.S.C. 957), by amend-21

ing subsection (a) to read as follows: 22

‘‘(a)(1) Except as provided in paragraph (2), no per-23

son may— 24

Page 22: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

22

† S 2032 ES

‘‘(A) import into the customs territory of the 1

United States from any place outside thereof (but 2

within the United States), or import into the United 3

States from any place outside thereof, any controlled 4

substance or list I chemical, or 5

‘‘(B) export from the United States any con-6

trolled substance or list I chemical, 7

unless there is in effect with respect to such person 8

a registration issued by the Attorney General under 9

section 1008, or unless such person is exempt from 10

registration under subsection (b). 11

‘‘(2) Paragraph (1) shall not apply to the im-12

port or export of marihuana or cannabidiol (as de-13

fined in section 2 of the Cannabidiol and Marihuana 14

Research Expansion Act) that has been approved 15

for— 16

‘‘(A) medical research for drug develop-17

ment authorized under section 201 of the 18

Cannabidiol and Marihuana Research Expan-19

sion Act; or 20

‘‘(B) use by registered manufacturers to 21

manufacture drugs containing marihuana or 22

cannabidiol that have been approved for use by 23

the Commissioner of Food and Drugs under the 24

Page 23: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

23

† S 2032 ES

Federal Food, Drug, and Cosmetic Act (21 1

U.S.C. 301 et seq.).’’. 2

TITLE III—DOCTOR-PATIENT 3

RELATIONSHIP 4

SEC. 301. DOCTOR-PATIENT RELATIONSHIP. 5

It shall not be a violation of the Controlled Sub-6

stances Act (21 U.S.C. 801 et seq.) for a State-licensed 7

physician to discuss— 8

(1) the currently known potential harms and 9

benefits of marihuana derivatives, including 10

cannabidiol, as a treatment with the legal guardian 11

of the patient of the physician if the patient is a 12

child; or 13

(2) the currently known potential harms and 14

benefits of marihuana and marihuana derivatives, 15

including cannabidiol, as a treatment with the pa-16

tient or the legal guardian of the patient of the phy-17

sician if the patient is a legal adult. 18

TITLE IV—FEDERAL RESEARCH 19

SEC. 401. FEDERAL RESEARCH. 20

(a) IN GENERAL.—Not later than 1 year after the 21

date of enactment of this Act, the Secretary of Health and 22

Human Services, in coordination with the Director of the 23

National Institutes of Health and the heads of other rel-24

evant Federal agencies, shall submit to the Caucus on 25

Page 24: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

24

† S 2032 ES

International Narcotics Control, the Committee on the Ju-1

diciary, and the Committee on Health, Education, Labor, 2

and Pensions of the Senate and the Committee on Energy 3

and Commerce and the Committee on the Judiciary of the 4

House of Representatives a report on— 5

(1) the potential therapeutic effects of 6

cannabidiol or marihuana on serious medical condi-7

tions, including intractable epilepsy; 8

(2) the potential effects of marihuana, includ-9

ing— 10

(A) the effect of increasing delta-9- 11

tetrahydrocannabinol levels on the human body 12

and developing adolescent brains; and 13

(B) the effect of various delta-9- 14

tetrahydrocannabinol levels on cognitive abili-15

ties, such as those that are required to operate 16

motor vehicles or other heavy equipment; and 17

(3) the barriers associated with researching 18

marihuana or cannabidiol in States that have legal-19

ized the use of such substances, which shall in-20

clude— 21

(A) recommendations as to how such bar-22

riers might be overcome, including whether pub-23

lic-private partnerships or Federal-State re-24

search partnerships may or should be imple-25

Page 25: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

25

† S 2032 ES

mented to provide researchers with access to 1

additional strains of marihuana and 2

cannabidiol; and 3

(B) recommendations as to what safe-4

guards must be in place to verify— 5

(i) the levels of tetrahydrocannabinol, 6

cannabidiol, or other cannabinoids con-7

tained in products obtained from such 8

States is accurate; and 9

(ii) that such products do not contain 10

harmful or toxic components. 11

(b) ACTIVITIES.—To the extent practicable, the Sec-12

retary of Health and Human Services, either directly or 13

through awarding grants, contacts, or cooperative agree-14

ments, shall expand and coordinate the activities of the 15

National Institutes of Health and other relevant Federal 16

agencies to better determine the effects of cannabidiol and 17

marihuana, as outlined in the report submitted under 18

paragraphs (1) and (2) of subsection (a). 19

Passed the Senate December 15, 2020.

Attest:

Secretary.

Page 26: S. 2032...3 †S 2032 ES 1 trolled substance on the schedule that is applicable 2 to cannabidiol or marihuana, as applicable; 3 (2) the term ‘‘cannabidiol’’ means— 4 (A)

11

6T

HC

ON

GR

ES

S

2D

SE

SS

ION

S. 2032

AN

AC

T

To ex

pan

d resea

rch o

n th

e can

nabid

iol a

nd

marih

uan

a.